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The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion

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ClinicalTrials.gov Identifier: NCT04843995
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
NorthShore University HealthSystem

Brief Summary:
The purpose of this prospective cohort study is to investigate the effect of sling on urethral dynamic shape and motion using static and dynamic pelvic floor ultrasound and additionally compare the findings among women with successful vs failed surgical outcome.

Condition or disease Intervention/treatment
Stress Urinary Incontinence Procedure: Mid-urethral sling

Detailed Description:

This study is designed as a prospective cohort study. Our hypothesis is that mid-urethral sling provides backstop for excessive "swing motion" of distal urethra and helps with urethral compression along its luminal axis.

Aim 1: Investigate the effect of mid-urethral sling on the urethral shape at rest and maximum Valsalva, in other words dynamic urethral shape.

Aim 2: Compare the effect of mid-urethral sling on urethral dynamic shape in women with successful surgical outcome (absence of stress urinary incontinence at 3 and 12 months after the surgery) and women with surgical failure (presence of stress urinary incontinence at 3 and 12 months after the surgery).

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion
Actual Study Start Date : January 11, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Mid-urethral sling
    Treatment of stress urinary incontinence with retropubic mid-urethral sling


Primary Outcome Measures :
  1. Urethral Shape at 3 months [ Time Frame: 3 months ]
    Urethral shape measured by ultrasound

  2. Urethral Motion at 3 months [ Time Frame: 3 months ]
    Urethral motion measured by ultrasound

  3. Urethral Shape at 12 months [ Time Frame: 12 months ]
    Urethral shape measured by ultrasound

  4. Urethral Motion at 12 months [ Time Frame: 12 months ]
    Urethral motion measured by ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Women over 18 years old with stress urinary incontinence interested in treatment with midurethral sling
Criteria

Inclusion Criteria:

  • stress urinary incontinence interested in treatment with mid-urethral sling
  • able to consent in english and come to post-operative and research visits

Exclusion Criteria:

  • contraindication to mid-urethral sling
  • detrusor overactivity > 40cm H2O
  • post-void residual > 150mL
  • Maximum urethral closure pressure < 40 cm H2O

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843995


Contacts
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Contact: Joel D Winer, MD 2242512374 jwiner@northshore.org
Contact: Ghazaleh Rostami Nia, MD 2242512374 grostami@northshore.org

Locations
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United States, Illinois
NorthShore University HealthSystem Recruiting
Skokie, Illinois, United States, 60076
Contact: Joel Winer, MD    224-251-2374    jwiner@northshore.org   
Sponsors and Collaborators
NorthShore University HealthSystem
Investigators
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Principal Investigator: Joel D Winer, MD NorthShore University HealthSystem
Study Chair: Ghazaleh Rostami Nia, MD NorthShore University HealthSystem
Publications:

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Responsible Party: NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT04843995    
Other Study ID Numbers: EH21-027
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations